Skin Clinic, The

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/30/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the histotechnology supervisor and medical assistance at the conclusion of the survey. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on a review of records and interview with the histotechnology laboratory supervisor, the laboratory failed to document the reactivity of the H&E (Hematoxylin & Eosin) stain each day of testing for one of ten days of patient testing. Findings include: (1) On 07/30/2025 at 09:45 am, the histotechnology laboratory supervisor stated the laboratory performed microscopic interpretations of histology (Mohs and skin biopsy) specimens that had been stained with H&E stain; (2) A review of test records for ten days of patient testing (microscopic interpretations) performed between 12/05/2024 and 07/10/2025 identified no evidence that the reactivity of the stain had been observed for acceptability for one (02/27/2025) of the ten days of patient testing reviewed; (3) The findings were reviewed with the histotechnology laboratory supervisor who stated on 07/30/2025 at 11:00 am, the reactivity of the stain was observed for acceptability on each patient slide but had not been documented as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/11/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the histology technician during an exit conference performed at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the histology technician, the laboratory failed to ensure that one of one expired reagent was not available for use. Findings include: (1) Observation of the laboratory on 10/11/2023 at 10:19 am identified the following reagent stored in the flammable cabinet that appeared to be available for use: (a) One bottle of Mercedes Scientific Platinum Line Xylenes, lot #2026901 with an expiration date of 03/31/2023. (2) The finding was reviewed with the histology technician who stated on 10/11/2023 at 10:23 am, the reagent was available for use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/27/2021. The findings were reviewed with the histotechnician at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the histotechnician, the laboratory failed to document the reactivity of the H&E (Hematoxylin & Eosin) stain each day of testing for four of 52 days of patient testing. Findings include: (1) On 12/27/2021 at 11:15 am, the histotechnician stated the laboratory performed microscopic interpretations of histology (Mohs and skin biopsy) specimens that had been stained with H&E (Hematoxylin & Eosin) stain; (2) The surveyor reviewed test records for 52 days of patient testing (microscopic interpretations) performed from 01/06/2021 through 12/16/2021. There was no evidence that the reactivity of the stain had been observed for acceptability for four (03/12/2021, 05/28/2021, 10/22/2021, and 11/05 /2021) of the 52 days; (3) The surveyor reviewed the findings with the histotechnician who stated on 12/27/2021 at 12:23 pm, the reactivity of the stain was observed for acceptability on each patient slide, but had not been documented as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --